C3 Glomerulopathy (C3G)NCT05222412
Managed Access Programs for LNP023, Iptacopan
A study testing Iptacopan in people with C3 Glomerulopathy (C3G) and Paroxysmal Nocturnal Hemoglobinuria (PNH), run by Novartis Pharmaceuticals.
Trial summary
The purpose of this registration form is to list all Managed Access Programs (MAPs) related to LNP023, Iptacopan Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- C3 Glomerulopathy (C3G), Paroxysmal Nocturnal Hemoglobinuria (PNH)
- What is being tested?
- Iptacopan
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An independent request should be received from a licensed physician (in some instances from Health Authorities, Institutions or Governments).
- The patient has a serious or life-threatening disease or condition and no comparable or satisfactory alternative therapy is available for diagnosis, monitoring or treatment; patient is not medically eligible for available treatment alternatives or has exhausted all available treatment options.
- The patient is not eligible or able to enroll in a Novartis clinical trial or continue participation in a Novartis clinical trial.
- There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
- The patient must meet any other medical criteria established by the medical experts responsible for the product or by the Health Authority in a country (as applicable).
- Provision of the product will not interfere with the initiation, conduct or completion of a Novartis clinical trial or overall development program.
- Managed access provision is allowed per local laws/regulations.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
MAP requests are initiated by a licensed physician.https:// www.novart is.com/healthcare-professionals/managed-access-programs contact
Novartis Pharmaceuticals contact
About this study
The purpose of this registration form is to list all Managed Access Programs (MAPs) related to LNP023, Iptacopan
Read the detailed description
- CLNP023B12004M - Available - Managed Access Program (MAP) Cohort Treatment Plan CLNP023B12004M to Provide Access to Iptacopan (LNP023) for Complement 3 Glomerulopathy in Native and Transplanted Kidneys.
- CLNP023N12001M - Available - Managed Access Program (MAP) Cohort Treatment Plan CLNP023N12001M to provide access to Iptacopan for patients with paroxysmal nocturnal hemoglobinuria (PNH).
- Being tested
- Iptacopan
- Keywords
- C3 glomerulopathy (C3G), Paroxysmal nocturnal hemoglobinuria (PNH), MAP, Manage access program, Iptacopan, LNP023
- Medical subject headings
- Hemoglobinuria, Paroxysmal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IptacopanDrug
Also called LNP023
Patients receive Iptacopan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C3 Glomerulopathy (C3G)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222412
- Sponsor's protocol ID
- CLNP023B12004M
- Status last verified
- Dec 2025
- First submitted
- 18 Jan 2022
- Last updated
- 5 Dec 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managed Access Programs for LNP023, Iptacopan
- ClinicalTrials.gov ID
- NCT05222412
- Acronym / sponsor ID
- CLNP023B12004M
- Keywords
- C3 glomerulopathy (C3G), Paroxysmal nocturnal hemoglobinuria (PNH), MAP, Manage access program, Iptacopan, LNP023
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this registration form is to list all Managed Access Programs (MAPs) related to LNP023, Iptacopan
Detailed description
- CLNP023B12004M - Available - Managed Access Program (MAP) Cohort Treatment Plan CLNP023B12004M to Provide Access to Iptacopan (LNP023) for Complement 3 Glomerulopathy in Native and Transplanted Kidneys.
- CLNP023N12001M - Available - Managed Access Program (MAP) Cohort Treatment Plan CLNP023N12001M to provide access to Iptacopan for patients with paroxysmal nocturnal hemoglobinuria (PNH).
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- An independent request should be received from a licensed physician (in some instances from Health Authorities, Institutions or Governments).
- The patient has a serious or life-threatening disease or condition and no comparable or satisfactory alternative therapy is available for diagnosis, monitoring or treatment; patient is not medically eligible for available treatment alternatives or has exhausted all available treatment options.
- The patient is not eligible or able to enroll in a Novartis clinical trial or continue participation in a Novartis clinical trial.
- There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
- The patient must meet any other medical criteria established by the medical experts responsible for the product or by the Health Authority in a country (as applicable).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IptacopanAlso: LNP023Patients receive Iptacopan | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MAP requests are initiated by a licensed physician.https:// www.novart is.com/healthcare-professionals/managed-access-programs contact
Novartis Pharmaceuticals contact
Questions about this trial
What is this clinical trial studying?
A study testing Iptacopan in people with C3 Glomerulopathy (C3G) and Paroxysmal Nocturnal Hemoglobinuria (PNH), run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MAP requests are initiated by a licensed physician.https:// www.novart is.com/healthcare-professionals/managed-access-programs (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.